Reduced pressure therapy of the sacral region

ABSTRACT

Reduced pressure wound therapy is performed on a sacral region of a patient using an adhesive dressing comprising a flexible planar layer and a non-planar fold-sealing region configured to seal to the intergluteal cleft of a patient. The fold-sealing region is located on an outer edge of the adhesive dressing and comprises a tapered configuration.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims benefit under 35 U.S.C. §119(e) to U.S.Provisional Ser. No. 61/143,030, filed on Jan. 7, 2009, which is herebyincorporated by reference in its entirety.

BACKGROUND

Pressure sores or decubitus ulcers classically result from localizedtissue ischemia at pressure points on a patient's skin associated withimmobility. However, friction and maceration at the skin site may alsobe contributing factors. Common locations of decubitus ulcers includethe heel, the ankle, the sacral region, the coccygeal region, theischial region, the knee, and the elbow. Traditional therapy forpressure ulcers has focused on prevention of these ulcers, due to thedifficulty of treating the ulcers once they have formed. Thesetreatments include nursing protocols to frequently turn or change theposition of bedbound patients, as well as equipment to redistributefocal forces acting on a patient's skin, such as foam boots andfluidized beds. Recently, the delivery of reduced pressure wound therapy(RPWT) has shown promise in the treatment of decubitus ulcers.Typically, RPWT involves creating an enclosed space around a wound andconnecting this enclosed space to a reduced pressure source. Thecreation of the enclosed space is achieved most commonly with anadhesive-coated thin polyurethane film. A conduit, typically a port thatmay be connected to flexible tubing, from the enclosure created by theadhesive barrier usually is used to connect to the reduced pressuresource which facilitates reduced pressure application to the wound siteas well as removal of wound exudates. RPWT has been shown to accelerateor promote the healing of a variety of chronic wounds, includingdiabetic ulcers, venous stasis ulcers, surgical wounds and traumaticwounds.

BRIEF SUMMARY

Disclosed herein are devices and methods for reduced pressure therapy ofthe sacral region. A dressing system that accommodates the anatomicparticularities of the sacral region may be used to provide asubstantially airtight seal for RPWT.

One variation of a dressing system may comprise a base layer and asacral sealing region. The base layer may have a first and secondsurface, an interior region and an outer perimeter, where an adhesivelayer may be located on the second surface of the base layer andsubstantially along the outer perimeter of the base layer. The sacralsealing region may comprise a non-planar configuration with a peakregion that has a generally tapered shape. The tapered shape of thesacral sealing region may extend from the outer perimeter towards theinterior region of the base layer, and from the second surface of thebase layer to a peak region projecting from the second surface. Thesacral sealing region may be integrally formed with the base layer, ormay have a sacral sealing structure that may be attached to the baselayer. The sacral sealing structure may be attached at the point ofmanufacture, or may be attached at the point of use.

Some variations of a sacral sealing region may further comprise acavity. Optionally, a sacral sealing region may comprise a foam locatedin the cavity. A sacral sealing region may comprise an access valve incommunication with the cavity, where the access valve may be located ona first surface of the sacral sealing region.

A device that may be used to create a substantially airtight seal forRPWT may comprise a base layer and an adhesive located on the baselayer. The base layer may comprise a first surface, a second surface, aninterior region and an outer perimeter, and a non-planar sealing regionlocated about the outer perimeter of the base layer. The adhesive mayalso be located on at least a portion of the sealing region. Thenon-planar sealing region may be integrally formed with the base layer,or may be attached to the base layer at the point of manufacture. Somevariations of a non-planar sealing region may comprise one or moretapered regions with a taper length and slope, and one or more taperpeaks. Tapered regions may have one or more elastic regions configuredto change the taper slope when stretched. Certain variations of anon-planar sealing region may further comprise a cavity. Thesenon-planar sealing regions may further comprise a pushing elementlocated in the cavity, where the pushing element is configured to pushoutwardly against the cavity. In some variations, the pushing elementsmay comprise a filament that is coupled to a taper peak, and extendsalong a taper length. Pushing elements may also comprise a sackcontaining an expandable element, where the expandable element may be afoam or a fluid. The device may also further comprise tubing locatedwithin the base layer, tubing directly attached to the first surface orthe second surface of the base layer, or even directly attached to boththe first and second surface of the base layer.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts an anterior perspective view of an example of a dressingsystem that may be used for RPWT of the sacral region.

FIG. 2A is a schematic posterior view of a variation of a fold-sealingregion of a RPWT dressing. FIG. 2B is an interior elevational view ofthe dressing in FIG. 2A. FIG. 2C is a schematic posterior view ofanother variation of a dressing with a fold-sealing region comprisingone or more elastic regions. FIG. 2D is a posterior perspective view ofthe dressing in FIG. 2C and FIG. 2E schematically depicts the dressingof FIG. 2C applied to the sacral region of a patient. FIGS. 2F and 2Gschematically illustrate the dimensions of two examples fold-sealingregions. FIGS. 2H-2K depict variations of a fold-sealing regioncomprising a cavity. FIG. 2L depicts a variation of a dressing with arounded, bi-lobular geometry and a fold-sealing region comprising acavity.

FIG. 3A illustrates an anterior perspective view of a protective layerof a multi-layer dressing system. FIG. 3B is a posterior perspectiveview of an occlusive layer being applied to the protective layer of FIG.3A. FIG. 3C is an anterior perspective view of another example of amultilayer dressing system with a rounded bi-lobular geometry. FIG. 3Dis a posterior perspective component view of the dressing system in FIG.3C. FIGS. 3E and 3F are anterior and posterior perspective views of avariation of a dressing system with low-profile tubing.

FIGS. 4A-4C are exemplary cross-sectional views various low-profiletubing configurations that may be used with a dressing system.

FIGS. 5A-5C depict various dressing port configurations that may be usedwith a dressing system.

FIGS. 6A and 6B are posterior and anterior views of another dressingsystem comprising a port located on a tissue-contacting side of thedressing. FIG. 6C is a schematic cross-sectional view of the dressingsystem of FIG. 6A and 6B being applied to a treatment site.

FIG. 7A is a posterior view of another variation of dressing comprisingtubing integrated into the dressing layer. FIG. 7B is a cross-sectionalview of the dressing in FIG. 7A.

FIGS. 8A and 8B depict a variation of a dressing system comprisingmultiple ports.

FIG. 9 depicts one variation of a dressing system comprising multiplepeel-away layers.

FIG. 10A is a posterior view of a dressing configured for use with aninjectable adhesive. FIG. 10B is an anterior perspective view of anotherexample of a dressing configured for use with an injectable adhesive.FIG. 10C depicts the use of the dressing of FIG. 10B on a patient.

FIG. 11 shows another variation of a dressing configured for use with aninjectable adhesive.

FIGS. 12A and 12B are posterior and anterior perspective views of adressing, respectively, comprising a fillable fold-sealing region andconfigurable conduit system in a fully opened state; FIG. 12C depictsthe dressing of FIG. 12B with the configurable conduit system in apre-configured state.

FIGS. 13A and 13B are posterior and anterior perspective views ofanother dressing comprising a configurable conduit system in a fullyopened state; FIG. 13C depicts the dressing of FIG. 13B with theconfigurable conduit system in a pre-configured state.

FIG. 14 illustrates an anterior view of a dressing system with afold-sealing region comprising multiple elastic regions.

FIG. 15A depicts a posterior perspective view of a cushion device thatmay be used with the dressing systems described herein. FIG. 15B depictsthe cushion device of FIG. 15A used with a dressing on a patient. FIG.15C is a superior view of a dressing system with an integrated cushion;FIG. 15D depicts the use of the dressing system in FIG. 15C on apatient.

FIGS. 16A and 16B are posterior perspective views depicting additionalexamples of dressing systems with cushion regions.

FIG. 17A depicts another variation of a dressing system with a cushionand handles. FIG. 17B depicts the dressing system of FIG. 17A used on asacral region of a patient. FIGS. 17C and 17D are schematiccross-sectional views of the use of the dressing system of FIG. 17A.

FIGS. 18A-18D depict examples of support garments that may be used witha sacral dressing. FIG. 18B depicts a RPWT garment with sealable bands.FIGS. 18C and 18D are posterior and side elevational views of anotherexample of a sacral dressing support garment.

FIGS. 19A and 19B depict a variation of a dressing that may be used toflatten a skin fold and seal a treatment site.

FIG. 20A illustrates a schematic anterior view of a diaper system withan RPWT dressing, and a vacuum tube to remove fecal matter. FIGS. 20Band 20C are anterior and cross-sectional views of another variation of adiaper system with an RPWT dressing and a vacuum tube to remove fecalmatter.

FIG. 21 depicts another variation of a protective layer of a multi-layerdressing system.

FIGS. 22-24 illustrate a variety of other configurations of a sacraldressing system.

FIG. 25 depicts an example of a tri-flap dressing system.

DETAILED DESCRIPTION

Some anatomical regions have contours or geometries that makeapplication of a pre-fabricated planar dressing more challenging,especially for RPWT where a seal between the skin and dressing is usedto generate therapeutic vacuum at the wound site. For example, someanatomical regions that have rounded protrusions, one or more curves,protrusions, infolds, creases, indentations, and/or crevices, may affectthe formation of an airtight seal between the dressing and the skinsurface. Examples of anatomic locations where this may occur are aroundor between finger and toes, between folds of fatty tissue, the axilla,the groin, the perineal region, the antecubital fossa, the inframammaryfold, etc. Many traditional dressings are not adapted to be easilypositioned within the abrupt curves and indentations of a skin fold, andare not easily adhered to the skin of a crease or fold to create asufficiently airtight seal for RPWT.

The complex contours of the sacral region pose a particular challenge toapplying a substantially airtight dressing for RPWT. The sacral regioncomprises gluteal regions and an intergluteal cleft. Other skin foldsadjacent to the sacral region include the gluteal creases that separateeach gluteal region from the thigh. The anatomical delineations providedby the cleft and creases may vary depending upon elasticity of the skinand/or loss of muscle mass. The intergluteal cleft is located betweenthe two gluteal regions, and generally forms an angular shape, e.g.,triangular, where the apex of the angle points into the cleft fold. Dueto the narrow width and the steep taper of the cleft, it may bedifficult to apply a dressing to the skin within the cleft to create anadequate seal. Additionally, the shape and size of the interglutealcleft and gluteal regions may vary for different patients. Thevariability of the skin contours may increase the number of leakagechannels of a typical dressing when applied to the skin in these areas.

In addition to challenges due to varied anatomical contours, maintaininga sufficiently airtight seal between a dressing and a folded skinsurface for RPWT is subject to other factors that can affect the seal ofthe dressing. These factors may include mechanical deformation caused bypatient movement, accumulation of moisture (e.g., sweat or interstitialfluid), and by the reduced pressure itself. In addition, adhesive filmscan, upon removal, be traumatic to the delicate peri-wound skin, whichmay make it difficult to treat smaller satellite wound lesions in theseareas.

For example, forming a dressing seal in the sacral region can also becompounded by motion in the region during various activities, forexample, bathing or physical therapy for bedridden patients or dailyactivity for mobile patients. The flexion and movement of tissue in thesacral region, as well as the accumulation of moisture and possiblyfecal matter, may also make it difficult for dressings to create anadequate seal. The motion of tissue can further contribute toprogressive separation of dressing adhesive surfaces from desiredsealing surfaces.

Disclosed herein are dressings that may be used with RPWT of the sacralregion and other folded, creased, contoured or clefted regions of thebody. The dressing may provide a substantially airtight seal in thesacral region by closely approximating the contours of the sacral regionso that the dressing may adhere to the skin surface with fewer leakagechannels. Methods of applying dressings to the sacral region to attainan airtight seal are also described herein.

In some examples, the dressing for RPWT may be configured to form anairtight seal around the gluteal region, the gluteal folds, and/or theintergluteal cleft. Since the dimensions and shape of the gluteal regionand the intergluteal cleft vary for individual patients, the dressingfor RPWT may have different geometries and sizes to accommodate thisvariety in anatomy. In addition, because the sacral region may be a siteof increased moisture accumulation due to sweat, excrement of fecalmatter, and reduced exposure to air (e.g., sitting or lying obstruct airflow to the buttocks area), the adhesive of a RPWT dressing may besubstantially moisture-resistant, such that the adhesive bond is notsignificantly or quickly affected by moisture. In other examples, theadhesive may be moisture-absorbent to reduce maceration of the adheredskin, and may also be selected to weaken over time to reduce peri-woundtissue damage when the dressing is removed. The dressing or dressingsystem may also be configured to reduce pressure points in the sacralregion, and may be arranged to treat multiple wound sites. Supportiveundergarments and devices may also help the RPWT dressing maintain anadequately airtight seal in the sacral region as the patient assumes anyposition (e.g., sitting, standing, lying, etc.) or movement (e.g.,walking, rolling, bending, etc.).

Generally, dressings for RPWT may comprise a substantially planarstructure with an adhesive surface, that acts as an occlusive coverlayer or base layer which is then applied over the wound after fillingthe wound with a contact material such as gauze, foam, or other porousmaterials. The contact material may reduce dead space in the wound, andmay provide cushioning and distribute the reduced pressure throughoutthe wound bed. The adhesive covering may create a substantially airtightenclosure which encompasses the wound. This enclosure may be in fluidconnection with a reduced pressure source. The reduced pressure sourcemay comprise an electric vacuum pump, in-wall suction, or anon-electrically powered suction device. The fluid connection betweenthe vacuum source and the occlusive covering may be provided by aconduit which communicates with an opening in the occlusive covering. Insome variations, the conduit may pass through the dressing to be influid communication with the wound bed.

In some variations, dressings for RPWT of the sacral region may comprisea planar region for sealing with the skin of the portion of the glutealregion, and a non-planar region that may protrude from the planar regionthat is adapted to form a sufficiently airtight seal with the skin ofthe intergluteal cleft. This non-planar region may have one or morepre-formed shapes, such as peaks and/or tapered regions, and mayfacilitate adhesion to folds or creases in the intergluteal cleft. Insome variations, the fold-sealing region is formed from the planarregion. For example, the planar region may be pre-folded, pre-creased,and/or scored to form the fold-sealing region, and then heat-set orchemically treated to maintain a non-planar shape. In other variations,the fold-sealing region may be formed with the planar region, forexample, by injection molding, liquid injection molding, compressionmolding, transfer molding, and the like. Fold-sealing regions may alsobe formed separately from the planar region of the dressing, andattached to the planar region using an airtight mechanism prior to, orduring, use. In this variation, fold-sealing regions of different sizesand shapes may be chosen to best accommodate a patient's anatomy, andsubsequently attached to the planar portion of the dressing to create anairtight seal along and within the intergluteal cleft. The fold-sealingregion and the planar dressing layer may be integrally formed or may bejoined together at an airtight interface. In the latter example, thefold-sealing region may be joined to the dressing layer by heat-sealing,radio-frequency welding, laser welding, ultrasonic welding, solventwelding, polymer adhesives, and the like.

Certain variations of a dressing for RPWT may also have fold-sealingregions or structures that incorporate or are configured to accommodatea port or tubing used to connect the wound bed with a reduced pressuresource. The port and/or tubing may have a low-profile and besubstantially flat, which may help to reduce pressure points introducedby the dressing in the sacral region when the patient is in the sittingor prone position. Commonly utilized conduits, ports, and tubing thatmay be used to provide reduced pressure therapy at a wound site havebeen described in pending U.S. patent application Ser. No. 12/626,426,filed on Nov. 25, 2009, which is hereby incorporated by reference in itsentirety.

As stated previously, the fold-sealing region may itself be non-planar,e.g., may be three dimensional, with a length, depth, and width. Thedegree to which the fold-sealing region protrudes from the planarregion, i.e. the depth, may be selected in part by the depth of theintergluteal cleft of the patient, and may be sized so that thefold-sealing region adheres to the skin along the contours of the cleft.Additionally, the fold-sealing region may be located at an outer edge ofthe dressing, such that the width of the fold-sealing region extendsalong at least a portion of the outer edge. Optionally, the fold-sealingregion width may be located along a first edge, and the width may extendbetween a second and/or third edge. The width and length of fold-sealingregion may be selected so that a sufficiently airtight seal may beformed at or near the intergluteal cleft, relative to the location ofthe sacral or coccygeal wound, or at any other contoured anatomy siteadjacent to a skin treatment site.

One example of a dressing (100) for RPWT of the sacral region is shownin FIG. 1, which depicts the skin-contacting surface, i.e., lowersurface (110) or anterior surface (relative to the anatomical positionof the patient), of the dressing (100) that is opposite of the uppersurface (112) or posterior surface (relative to the anatomical positionof the patient). The dressing (100) comprises a base layer (108), a port(not shown) that may be in fluid connection with a sacral wound, tubing(102) that may provide a conduit between a reduced pressure source andthe wound bed via the port, and a fold-sealing region (106) located onone edge of the base layer (108). Variations of ports and tubing thatmay be used with a dressing for RPWT have been described in pendingapplication U.S. application Ser. No. 12/626,426, filed on Nov. 25,2009, which has been previously incorporated by reference in itsentirety.

The fold-sealing region may have creases, folds, bends, curves,protrusions, ridges, projections, perforations, and the like, that mayhelp the fold-sealing region closely approximate the skin contours ofthe intergluteal cleft for the formation of a substantially airtightseal. The fold-sealing region may be pre-configured to protrude from thebase layer and may approximate the contour of the skin along theintergluteal cleft. The fold-sealing region (106) further comprises anadhesive region on the skin-contacting surface to create an airtightseal with the skin in the intergluteal cleft. As described previously,the intergluteal cleft may form an angle with an apex within the cleftfold. Similarly, the fold-sealing region may have a tapered or anangular shape, such as a triangular shape, that may facilitate sealingof the dressing along the taper of the intergluteal cleft. In somevariations, the fold-sealing region may have a shape with a taperedregion that fits into the crease of the intergluteal cleft. For example,the fold-sealing region may be shaped similar to a pyramidal ortriangular prism or tent, where a tapered portion of the prism or tentmay be configured to fit into the crease of the intergluteal cleft. Afold-sealing region may also be crest-shaped, with a rounded ovalportion tapered at one end. The tapered region of the crest may beshaped to fit along the skin surface of the upper portion of theintergluteal cleft and/or the gluteal regions. In some variations, afold-sealing region may be tapered along a length that is parallel tothe longest dimension of the intergluteal cleft, such that the widestportion of the taper is along an outer edge of the dressing, and thenarrowest portion of the taper is located towards the center of thedressing. The fold-sealing region may also be configured to be malleableso that it can be stretched and deformed into a trough or depression tofit creases, folds, and clefts in sacral regions that may have differentdimensions and geometries. This may help mitigate introduction ofadditional pressure points to the sacral region, as well as create andmaintain an adequately airtight seal. In some variations, the skincontact portion of the fold-sealing region may be made of the sameocclusive material as the other portions of the dressing base layer. Thefold sealing region may comprise a structure that is integrally formedwith the occlusive cover or may be separately formed and attached, ormay be formed by folding and attaching a portion of the occlusive coverback onto itself. The fold-sealing structure may be open or closedshape, and may have a solid, hollow, or porous interior. Examples andother variations of the base layer and the fold-sealing region aredescribed below.

In the example of FIG. 1, the fold-sealing region (106) comprises aclosed triangular pyramidal shape having an inferior face (114) locatedat an outer edge (116) of the dressing (110) and an interior corner orapex (118) located between the base and the interior of the dressing(110), e.g. toward the central vacuum opening (120) of the dressing(110). In some configurations, the inferior face (114) is generallyoriented in a plane that is perpendicular to the general plane of thedressing (100), but in other examples, the base face may be generallyoriented in a plane that is at a non-perpendicular angle. The region(106) further comprises an anterior apex (122) comprising the point orarea of the region (106) that is the greatest distance from the generalplane of the dressing (100). The region (106) also comprises an anteriorcrest (124) between the anterior apex (122) and the interior apex (118),along with a base face (not seen in FIG. 1) that is generally co-planarwith the general plane of the dressing (100), and two side faces (126)to each side of the crest (124). The crest may have a linear ornon-linear configuration, including generally convex and concaveconfigurations. In other examples, the fold-sealing region may comprisean anterior surface rather than an anterior crest or fold. The interiorof the fold-sealing region (106) may be solid, may be porous or maycomprise a one or more cavities. The surfaces of the fold-sealing region(106) may comprise the same or different materials as the materialscomprising the anterior and posterior

FIG. 2A illustrates another example of a dressing (200) for RPWT. Asshown there, a base layer (204) has a plurality of pre-configured foldsor creases (202), where the creases (202) may form a general Y-shape.Creases and/or folds on the substantially planar base layer (204) mayhelp the substantially two-dimensional base layer (204) accommodate thecontour of the sacral region or facilitate initial positioning of thedressing (200) into the intergluteal cleft by folding the dressing alongthe creases (20). The portion of the base layer that is enclosed in theY-shaped crease (202) forms a fold-sealing region (206) when the creasesare folded. FIG. 2B depicts one example of how a non-planar, pre-formedfold-sealing region (206) may form a seal along a sacral contour (205)that has a curved indentation, e.g., a wound bed. Optionally, thedressing (200) may have a midline crease (203). The fold-sealing region(206) may be sized according to the geometry of a patient's interglutealcleft. The dimension (D1) may be determined in part by the depth of theintergluteal cleft and may be a multiple of that depth, e.g., dimension(D1) may be approximately less than, equal to or more than twice thedepth of a patient's intergluteal cleft or the depth to which thepractitioner determines is necessary for the dressing (200) to providean airtight seal with the skin of the intergluteal cleft of theparticular patient in question. The dimension (D2) may be determined inpart by the length of the intergluteal cleft. While the fold-sealingregion (206) is shown to be formed from the dressing (200), in othervariations of a dressing for RPWT for the sacral region, thefold-sealing region may be separately manufactured and then attached tothe dressing prior to use.

Sacral dressings may also comprise highly deformable regions, e.g.,elastic or flexible regions, which are more compliant than the bulk ofthe dressing layer. An elastic region may provide greater conformabilityto the contours of the sacral region. After being stretched, the one ormore elastic regions may be able to return to its un-stretched shape,e.g., may have shape-memory. The stretching may be performed, forexample, as the dressing is being applied to the patient, or may occurduring patient movements, such as walking, sitting, bending, etc. Insome examples, the 100% elastic modulus of the elastic region may be inthe range of about 0.1 pound-force (lbf) to about 2 lbf for every 25 mmwidth of the material comprising the elastic region, wherein the widthis transverse to the direction of tension exerted onto the material. Inother examples, the 100% elastic modulus may be in the range of about0.5 lbf to about 1 lbf per 25 mm width, or about 0.3 lbf to about 1.5lbf per 25 mm width of material. In some variations, these elasticregions may be arranged along creases in the base layer and/or thefold-sealing region. One variation of a dressing with one or moreelastic regions is shown in FIG. 2C. Dressing (220) has a first elasticregion (222) and a second elastic region (224), where the first elasticregion (222) is arranged as a V-shape, and the second elastic region(224) is arranged as a V-shape nested in the V-shape formed by the firstelastic region (222). The first and second elastic regions may radiatefrom the portion of the dressing (220) which is configured to residealong a corner of the intergluteal cleft and extend toward the edges ofthe dressing (220) to help the dressing to conform to the contours ofthe intergluteal cleft more easily. The first and second elastic regionsmay be made of highly elastic dressing substrates and adhesives, such aselastic polyurethanes and acrylic or hydrocolloid adhesives.Alternatively, the dressing (220) may be made of a more elastic materialthat easily stretches and conforms to fit the contours of theintergluteal cleft. Providing elastic regions to a dressing, and/ormaking a dressing out of elastic materials may help the dressing to bendand conform to the body during normal body movement to reduce thepotential for stress concentrations that may lead to the separation ofthe dressing from the body. In other variations, the dressing (220) maycomprise an elasto-plastic or plastically deforming material which ishighly compliant and deformable to conform the contours of the patientanatomy. Tubing (221) may extend from a location that is co-linear withthe vertices of the first elastic region (222) and the second elasticregion (224), but in other variations the tubing (221) may be locatedanywhere on the dressing (220) that is in fluid communication with thewound bed. The tubing may comprise materials such as silicone, urethane,polyurethane, polyvinyl chloride (PVC), any of a variety ofthermoplastic elastomers (TPEs) such asstyrene-ethylene-butylene-styrene (SEBS), for example. The tubing (221)may have a low profile and pass through a cavity portion thefold-sealing region (226) to help reduce pressure points in the sacralregion when the patient is in a sitting or prone position. FIG. 2Dschematically depicts a perspective view the three-dimensional geometryof the dressing (220) when creased along the first elastic region (222)and the second elastic region (224). The tubing (221) may extend fromthe dressing (220) through the fold-sealing region (226). One example ofhow the dressing (220) may be applied to a patient (223) is shown inFIG. 2E, where the tubing (221) may extend from the dressing along theintergluteal cleft (225), between the two gluteal regions.

As mentioned previously, the fold-sealing region may be fin-shaped,tent-shaped, crest-shaped, or may be an appropriately shaped ridge,prominence, or other appropriate form factor. The geometry of variousfold-sealing regions or structures may be characterized in a variety ofways, as illustrated in FIGS. 2F and 2G. FIG. 2F depicts a variation ofa fold-sealing region (230), where the fold-sealing region (230) istapered such that the dimension (D3) varies along axis (A1), e.g.,dimension (D3) generally decreases along a taper length (L1) to a corneror apex (232). The dimension (D3) and the length (L1) may be variedaccording to the anatomy of the patient. Axis (A1) may be generallyperpendicular to the plane in which the rest of the dressing resides.The taper of fold-sealing region (230) may have any length (L1)according to the anatomy of the intergluteal cleft. The length (L1) maybe from about 1 centimeter to about 12 centimeters, for example, fromabout 1 centimeter to about 3 centimeters, or from about 2 centimetersto about 5 centimeters. The largest value of the dimension (D3), i.e.,the overall width of the fold-sealing region, may be from about 2centimeters to about 20 centimeters, for example, from about 3centimeters to about 5 centimeters, or from about 4 centimeters to about6 centimeters, or from about 8 centimeters to about 15 centimeters. Thedimension (D3) and the length (L1) may be varied according to theanatomy of the patient, for example, larger patients may have largerintergluteal clefts, and obese patients may have a deeper interglutealcleft. Some variations of a fold-sealing region may have a taper withone or more taper slopes (i.e., the change in dimension (D3) over alength along axis (A1)). For example, a fold-sealing region may have onetaper slope along the entire length of the taper, as exemplified in FIG.2F, or may have two or more taper slopes along the length of the taper,as exemplified in FIG. 2D. The taper of the fold-sealing region (226) inFIG. 2D has a first slope (M1), and a second slope (M2) that is greaterthan the first slope (M1), as the taper converges at apex (227). Theslopes of the tapers may be in the range of about 0.25 to about 1, orabout 1 to about 10, or about 5 to about 15, etc. In some variations,the fold-sealing region taper may converge at angle. For example, thefold-sealing region (230) has a taper that converges at the apex (232),where the apex (232) has an angle (V1). The angle (V1) may vary fromabout 0° to about 180°, sometimes about 10° to about 150°, or othertimes from about 10° to about 90°, and other times from about 20° toabout 50°. The various dimensions and geometries of the fold-sealingregion may be pre-configured or pre-shaped for a particular dressing,and a practitioner may have a variety of dressings with fold-sealingregions of different widths, depths, and lengths to choose from whenpreparing a patient for RPWT.

FIG. 2G depicts a variation of a fold-sealing region (240) comprisingmultiple tapered sections. A first additional taper (246) is formed byvarying dimension (D4) along axis (A2), e.g., dimension (D4) generallydecreases along length (L2) to an apex (242). A second additional taper(248) is formed by varying (D5) along axis (A3), e.g., dimension (D5)generally decreases along length (L3) to the corner or apex (244). Whilethe first and second additional tapers do not converge in thefold-sealing region (240), in some variations, the first and secondadditional taper sections may converge, i.e., apices (242) and (244) maybe coincident. As described above with regard to the taper in FIG. 2F,the first and second tapers may each have one or more taper ratios,slopes, and angles of convergence. For example, the first additionaltaper (246) may have any length (L2) according to the anatomy of theintergluteal cleft. The length (L2) may be from about 5 centimeters toabout 12 centimeters, for example, from about 4 centimeters to about 6centimeters, or from 6 centimeters to about 15 centimeters, or from 16centimeters to about 24 centimeters. The largest value of the dimension(D5), i.e., the width of the fold-sealing region, may be from about 2centimeters to about 10 centimeters, for example, from about 3centimeters to about 5 centimeters, or from about 4 centimeters to about6 centimeters. The largest value of the dimension (D4) may be from about1 centimeter to about 12 centimeters, from 2 centimeters to about 10centimeters, or from about 3 centimeters to about 6 centimeters, or fromabout 4 centimeters to about 8 centimeters. The first additional taper(246) may have one or more taper slopes, where the taper slopes may befrom about 0.25 to about 1, or from about 1 to about 10, or from about 5to about 15, etc. The first additional taper (246) may converge to apex(242) with an angle (V2), where V2 may vary from about 0° to about 180°,sometimes about 10° to about 150°, or other times from about 10° toabout 90°, and other times from about 20° to about 50°. The secondadditional taper (248) may have characteristics similar to, or in therange of the first additional taper (246).

Although the examples in FIGS. 2F and 2G depict configurations thattaper distally to a point or line from the base of the fold-sealingregion, in other variations, the peak or distalmost region of thefold-sealing region may taper to a surface, e.g. the fold-sealing regionmay comprise a truncated geometry, such as a frusto-conical shape or atrapezoidal cross-sectional shape. These variations may be furthercharacterized by the ratio of the largest value of dimension (D3) to thesmallest value of dimension (D3) about the peak or distalmost region. Insome specific examples, this ratio may be in the range of about 4:3 toabout 20:1, sometimes about 2:1 to about 10:1, and other times about 3:1to about 8:1. In variations where the peak region comprises a surface,this distalmost surface may be generally parallel or non-parallel withrespect to the base layer of the dressing. The skew angle between theplane of the base layer and the plane of the distalmost surface, ifpresent, may be in the range of about 1° to about 45° or more, sometimesabout 5° to about 30°, and other times about 10° to about 25°.

While corners or apices (232), (242), and (244) are shown to be acuteangles, i.e. pointed, in other variations, one or more may be rounded orblunt. Fold-sealing regions that may be used to create a sufficientlyairtight seal in the intergluteal cleft region for RPWT may have one ormore of the tapers described above, with any number of taper ratios,taper slopes and/or apical convergence angles, in any combination thatis suitable for forming a seal with the skin along the unique anatomicalcontours in the intergluteal cleft region of each patient. The taperratio, taper slope and the angle of the apex of any of the taperspreviously described may be adjusted (e.g., stretched, molded, etc.) asthe dressing is positioned in the sacral region near and into theintergluteal cleft. The fold-sealing region may also be configured tointerface with positioning aids that may help to attach the fold-sealingregion to the skin within the intergluteal cleft. Examples ofpositioning aids may include suture threads, inflatable members,surgical spreaders, etc. Fold-sealing regions may also be configuredaccommodate one or more conduits that form a connection between a lowpressure source and the wound bed.

The anatomically shaped fold-sealing regions described above may enclosea cavity, an example of which is shown in FIG. 2H. As depicted there,the fold-sealing region cavity (252) of fold-sealing region (250) may behollow. In some variations, to facilitate insertion of the fold-sealingregion into a fold or cleft, a spatula or other instrument with a flatedge may be used to push the fold-sealing region deeper. In othervariations, a line or ribbon that extends along the length of thefold-sealing region to help insert the fold-sealing region into thecleft, as well as to help press the adhesive portions of thefold-sealing region to the skin in the cleft. For example, the line orribbon may be tensioned and pulled against the posterior surface of thedressing, along the contours of the intergluteal cleft, to facilitatesealing of the dressing to the cleft. The suture may be removed after anairtight seal has been attained, or may be retained with the dressing tofacilitate adjusting the position of the dressing in the event that itis shifted during the treatment.

Other variations of attachment feature may contain an inflatable cavitythat may help the dressing form a substantially airtight seal in theintergluteal cleft. FIG. 2I depicts one variation of a fold-sealingregion (260) that comprises an airtight cavity (262), and a deformablematerial (264) within the airtight cavity (262). The airtight cavity(262) may generally conform to the shape of the fold-sealing region, andthe deformable material (264) contained therein may occupy the majorityof the volume of the airtight cavity (262). Adjusting the volume of theairtight cavity may also adjust the dimensions of the fold-sealingregion, e.g., increase the depth, length, and/or width of thefold-sealing region. The airtight cavity (262) and the deformablematerial (264) be formed in a wedge shape that may help to distributepressure and press down the adhesive portion (266) against the creviceskin when loaded (e.g., loaded by sitting or lying down). The airtightcavity (262) and the deformable material (264) may be a material that issufficiently conformable as to accommodate different anatomies as wellas to mitigate introduction of additional pressure points. For example,the airtight cavity (262) may be made of a polyurethane, a vinyl,silicone, thermoplastic elastomer or other suitable material, and thedeformable material may be a urethane foam, a gel, gas, liquid,semi-solid or other fluid material such as a viscous silicone. Thecavity may also be filled with particles having any of a variety ofshapes, sizes, elastic properties, including solid or hollowmicrospheres, foam beads or buckwheat, for example. In some instances,the particles may be suspended in a gel or liquid medium. Somevariations of a fold-sealing region may have a base region (265). Thebase region (265) may substantially co-planar with the dressing baselayer, or may bulge inwardly or outwardly from the plane of the dressingbase layer Likewise, other faces of the fold-sealing region may alsobulge inward or outward. In other variations, the airtight seal isconstructed such that it comprises an aperture through which the reducedpressure delivery tubing is directed, thereby reducing potential patientcontact pressure points caused by the reduced pressure delivery tubing.

Some variations of a fold-sealing region may comprise a port on the baseregion, where the port may provide communication to the cavity in thefold-sealing region cavity. The port may be located on the base or theinferior face of the fold-sealing region. The port may be used tointroduce and/or withdraw the deformable material described above. FIG.2J depicts another variation of a fold-sealing region (270) comprisingan inflatable cavity (272), a port (274) along a base region (275), andan adhesive portion (276). The inflatable cavity (272) may be expandedby injecting any of the materials described above, and/or a gas, such ashelium or nitrogen or ambient air, via the port (274). The pressure ofthe gas within the airtight volume can be selected to ensure anappropriate fit to the anatomy of the patient, and may then be reducedafter the appropriate fit has been attained. The volume of theinflatable cavity (272) may be adjustable to allow inflation ordeflation to accommodate individual intergluteal cleft sizes. Theinflation and/or deflation of the cavity may be performed any timeduring the application of the dressing to the treatment site, or evenduring treatment to accommodate anatomical changes related to increasedor reduced swelling, erythema, infection, delamination or otherphenomena. In some variations, the cavity may be deflated to some degreeif the treatment site develops signs of excessive pressure due prolongedincumbency on the inflated dressing. The cavity may be inflated before,during, or after a) positioning in a skin fold, b) adhesion to the skin,c) removal of the release liner, d) during treatment, and/or e) duringremoval of the dressing from the skin site. As described above, theinflation and/or deflation of the cavity may be temporarily increasedand then decreased. In some variations, the pressure may be temporarilyincreased to a range of about 2.0 atmospheres to 3.0 atmospheres (e.g.,about 1500 mmHg to about 2500 mmHg), and then reduced to be morephysiologically compatible, e.g., about 0.1 atmospheres or less (e.g.,about 100 mmHg or less). For example, the pressure within the cavity maybe increased temporarily during positioning of the dressing, forming anairtight seal, etc., and may be reduced during RPWT. In some variations,the dressing may be manufactured such that there is an initial pressurewithin the cavity of the fold-sealing region, for example, the cavitymay be pre-filled to have a pressure of about 0.1 atmospheres or less(e.g., 100 mmHg or less). Alternatively or additionally, the cavity maybe inflated at the point-of-use, as described above. The port (274) maybe an opening that is configured to be closed by suitable cap, e.g.,friction-fit, snap-fit, screw-fit cap. The port (274) may also be aone-way flow mechanism, for example, a one-way valve, such as a duckbillvalve, a slit valve, a spring valve, an umbrella valve or any othersuitable one-way valve known in the art. The size and shape of the port(274) may allow inflation of the cavity (272) by a small catheter, tubeor other suitable conduit. FIG. 2K depicts one variation of afold-sealing region (280) comprising an inflatable cavity (282) and acavity opening (284), where the cavity opening (284) is attached to atubular portion (288) with an end portion (287). Optionally, a one-wayvalve as described above may be provided in the inlet (284), tubularportion (288) and/or end portion (287). The end portion (287) may beconfigured to interface with any tubing or syringes used in the art, forexample, by friction-fit, snap-fit, screw-fit, Luer-Lok®, etc. Anothervariation of a rounded dressing (292) with an inflatable fold-sealingregion (290) is shown in FIG. 2L. As shown there, the fold-sealingregion port (294) may be a one-way valve as described above, which maynot have additional tubing protruding therefrom. This may help tomaintain the low-profile of the dressing (292) to limit localizedpressures on the sacral region when the patient is in a position thatplaces weight on the dressing (292).

In some examples, the fold-sealing regions may comprise a collapsed orcompressed configuration to facilitate its positioning in the skin foldor cleft. In some examples, the fold-sealing region may comprise aninflatable and/or deformable component may be compressed as it isinserted into the cleft, and then expanded to urge the fold-sealingregion to adhere to the skin in the intergluteal cleft. Expansion of theinflatable and/or deformable component may also help seat thefold-sealing region at the desired location in the sacral region. Oncethe dressing has been positioned at the desired location, the inflatableand/or deformable component may remain expanded to maintain thatposition, as well as to maintain the seal between the fold-sealingregion and the skin in the cleft. Alternatively or optionally, theinflatable and/or deformable component may be collapsed and withdrawnonce an initial seal is created between the fold-sealing region and thecleft. The inflatable and/or deformable component may also allow theuser to adjust the size of the fold-sealing region by regulating theexpansion of the fold-sealing region as the dressing is applied to thepatient. For example, the user may inject more or less fluid into thecavity of the fold-sealing region as suitable for creating asubstantially airtight seal to the skin in the intergluteal cleft.

Some variations of a dressing for RPWT may have multiple layers to helpcreate a robust airtight seal with the peri-wound skin, or to permitremoval or separation of a portion of the dressing system withoutdisturbing the adhesive seal between the skin and the dressing system.One variation of a two-layer dressing is shown in FIGS. 3A and 3B.Dressings for RPWT may have any number of layers, where each layer mayhave a different function. For example, layers of a dressing may serveto deliver therapeutic agents, provide moisture, wick away moisture,adhere to the skin, interface with a port or tubing to a reducedpressure source, allow breathability, protect the wound from theexternal environment, etc. The dressing (300) shown in FIGS. 3A and 3Bcomprises a protective cover layer or sheet (302) comprising an adhesiveapplied to one side to attach to the peri-wound skin and a sealant layer(312) which may comprise tubing (316), and is configured to releasablyattach to the upper surface (318) of the protective layer (302). In use,the protective layer (302) may be adhered to the peri-wound skin surfaceand together with the sealant layer (312) provides an occlusive coverfor RPWT. To resist damage to the peri-wound skin when accessing thetreatment site, the sealant layer (312) may be separated from theprotective layer (302) while the protective layer (302) remains adheredto the peri-wound skin.

The upper surface of the protective layer and/or the adhesive on thesealant layer (312) may be configured to separate from each other whenpeeled apart while the adhesive between the protective layer (302) andthe skin resists inadvertent separation when the sealant layer (312) ispeeled off. In some variations, the adhesive on the protective layer andthe sealant layer may be the same adhesive, but the surface propertieson the upper surface of the protective layer may facilitate peel-off ofthe sealant layer, which may be similar to the surface of a releaseliner. In other examples, the t-peel force or blunt probe tack force ofthe protective layer adhesive may be greater than the t-peel or bluntprobe tack force of the sealant layer.

The adhesive properties of the protective layer (302) may be uniform ornon-uniform over the lower surface of the protective layer (302), e.g.,stronger adhesives may be applied in certain regions, certain regionsmay lack adhesives, and/or may comprise increased thicknesses ordensities of adhesives may be applied in some areas, such as theperipheral edges than at the center. Adhesive agents that may be used toattach the protective layer (302) to the peri-wound site include but arenot limited to polyurethane materials, hydrocolloid or hydrogelmaterials, silicone, pressure-sensitive adhesives, acrylic adhesives,and the like. Adhesive agents may also be activated by moisture, UV,heat, etc. The adhesive portions of the fold-sealing region may beconfigured to have a gradient in adhesive strength or adhesivethickness, e.g., increased adhesive strength at the locations that forma seal with the skin of the intergluteal cleft, to help ensuremaintenance of adhesion in high flexion areas. Other examples ofadhesives that may be used are described in pending application Ser. No.12/626,426, filed on Nov. 25, 2009, which has been previouslyincorporated by reference in its entirety. In some variations, anantiperspirant material or a moisture absorbent material may be providedto control moisture accumulation in the adhesive portion.

In one example, a polyurethane dressing with hydrocolloid adhesive fromEuroMed (Orangeburg, N.Y.) may be used (product number CS20742). In thisparticular example, dressing comprises the following characteristics: aprobe tack in the range of about 200 grams to 600 grams, e.g., about 251grams to 564 grams or 323 grams, a liner Z-release force in the range ofabout 0.5 Newtons to about 3 Newtons, e.g., about 0.14 Newtons or lessthan 2 Newtons, a 100% modulus in the range of about 1.5 Newtons toabout 5 Newtons, e.g., about 2 Newtons to about 4.5 Newtons or 2.9Newtons, an elongation to break parameter in the range of about 90Newtons to about 300 Newtons, e.g., greater than 100 Newtons or 168Newtons, a release from plate parameter in the range of about 3 Newtonsto about 15 Newtons, e.g., from about 5 Newtons to about 13 Newtons or 7Newtons, a water absorption (over 24 hours) parameter in the range fromabout 125 mg/cm^2 to about 500 mg/cm^2, e.g., greater than 150 mg/cm^2or 387 mg/cm^2, a thickness (adhesive and backing layer) in the range ofabout 0.2 millimeters to about 0.3 millimeter, about 0.2 millimeters toabout 2 millimeters, e.g., from about 0.42 millimeters to about 0.62millimeters or 0.49 millimeters, a length in the range from about 10centimeters to about 20 centimeters, e.g., about 14.8 centimeters toabout 15.2 centimeters or 15 centimeters, and a width in the range fromabout 10 centimeters to about 20 centimeters, e.g., about 14.8centimeters to about 15.2 centimeters or 15.2 centimeters. Variations ofthe dressing may be permeable, semi-permeable, or impermeable to gasand/or liquid. Descriptions of various sheets, base layers,configurations, types, dimensions, and materials may be also found inpending application Ser. No. 12/626,426, filed on Nov. 25, 2009, whichhas been previously incorporated by reference in its entirety.

Adhesive portions of a dressing for RPWT at the sacral region may becovered by release liners to preserve adhesive properties until readyfor adherence, and/or carrier elements or additional liners to maintainthe shape of the dressing during application. In some variations, acarrier element and/or release liner may also have sufficient rigidityto support the shape of the dressing while it is applied to the skin,and may have release handles or liners to reduce inadvertent adherenceto the user or the patient. In some variations, the carrier element mayhave a release liner that may be removed prior to applying the dressing.Carrier elements and release liners may have any suitable shape, such asa triangular, rectangular, or round shape, according to the shape of thefold-sealing region. Additionally, release liners may have break linesin different locations on the dressing to help facilitate theapplication of the dressing so that an airtight seal may be formed. Forexample, a break line may be located on a central apex and/or taperededge of a fold-sealing region, e.g., along the midline (203), with ahandle on each side of the break line. This configuration may allow theuser to apply the adhesive portion to the skin in the deepest portion ofthe intergluteal cleft first by peeling the two handles away from eachother, e.g., in generally opposite directions. As the handles are peeledaway from the break line and/or from each other, the adhesive portion ofthe fold-sealing region may be exposed and gradually smoothed outward,e.g., away from the intergluteal cleft. The direction in which thehandles are peeled away may be along the intergluteal cleft, orperpendicular to the cleft. Generally, one handle or release liner maybe peeled at a time, or multiple release liners may be peeledsubstantially simultaneously. Pressing and/or smoothing the adhesivelayer against the skin surface as the release liner is peeled may helpreduce the occurrence of leak channels in the dressing, and provide asubstantially airtight seal. The dressing adhesive may also betemperature sensitive such that the dressing may be repositionedmultiple times until positioned in the desired manner at which time heatactivation of the adhesive. For example, application of external heatcan facilitate sufficient adhesive flow to allow the adhesive to achievemore intimate contact with the skin surface. Heat-activated flow mightoccur with constituent adhesive materials with glass transitiontemperatures above body temperature (37° C.). Heat-activated adhesionmight also arise due to temperature-sensitive bond manipulation thatopens up molecular chains for adhesion to the skin surface. In furtherexamples, the dressing adhesive may be re-heated after the dressing hasbeen applied to the skin to permit repositioning or removal of thedressing, or to re-adhere a portion of the dressing that may haveseparated from its attachment site. Other variations of carrierelements, release handles, release liners, and any support layers aredescribed in pending application Ser. No. 12/626,426, filed on Nov. 25,2009, which has been previously incorporated by reference in itsentirety.

The protective layer (302) may comprise a central opening or mayoptionally comprise an inner layer (310) and a fold-sealing region(304), which may be any of the fold-sealing regions previouslydescribed. The inner layer (310) comprises an opening (306) and may ormay not comprise an adhesive on its lower surface. In some examples, theopening (306) is a vacuum opening. In further variations, opening (3060may also be used to insert scissors or other cutting instrument tofacilitate trimming of the inner layer (310) and increase exposure ofunderlying wound to the sealant layer 312). In some variations, theinner layer (310) may comprise a flexible or plastically moldablematerial that may be cut or deformable to the edge shape or othercontour of the wound bed. For example, the inner layer (310) maycomprise a thinner material that is easier to trim and accommodate thewound size and geometry, or may be pre-configured to accommodate mostwound geometries. Optionally, the inner layer (310) may comprise atransparent or translucent sheet or material (308). In other variations,the sealant layer (312) may be configured to attach to the inner region(308) rather than the upper surface (318) of the outer layer (320) ofthe protective layer (302), or to both the inner region (308) and theouter layer (320). The outer layer (320) and/or inner layer (310) may beuniformly thick, or may have regions of different thicknesses, i.e., theinner layer may be thicker or thinner than the outer layer. In theexample depicted in FIG. 3A, the inner layer (310) is recessed from theupper surface (318) of the outer layer (320), but in other examples theinner layer may protrude or may be in continuity with the upper surface(318) of the outer layer (320). The thickness of the protective layer(302), the inner layer (310), and adhesive properties may depend on anumber of factors, for example, the size of the wound and the conditionof the peri-wound skin.

FIG. 3B depicts an anterior perspective view of the dressing (300) withthe sealant layer (312) positioned over the protective layer (302) forattachment. As stated previously, the sealant layer (312) may be shapedand sized with an adhesive edge that is greater in size and shape to thesize and shape of the inner layer (310). This configuration permits thesealant layer (312) to seal to the upper surface (318) of the protectivelayer (302), and to provide fluid communication with the opening (306)of the inner layer (310). In other variations, the sealant layer may beconfigured to seal against the inner layer or a combination of the innerlayer and outer layer. The port (314) may be positioned at any suitablelocation on the sealant layer, and may be configured to rotate withrespect to the sealant layer (312). Both the tubing (316) and the port(314) may have a low profile which may help to reduce any pressurepoints to the sacral region when the patient is in a sitting or proneposition. Additional description of ports and tubing that may be usedwith a dressing for RPWT may be found in pending application Ser. No.12/626,426, filed on Nov. 25, 2009, which has been previouslyincorporated by reference in its entirety.

While the protective layer (302), its inner layer (308), and the sealantlayer (312) illustrated in FIGS. 3A and 3B are generally rectangular,any shape that be used for each of the structures. For example, theprotective layer, inner layer, and/or sealant layer may be generallytriangular, elliptical, rounded with two or more indentations, and thelike. Some variations of the protective layer, the transparent innerlayer, and the sealant layer may also have slits or pre-formed creasesto help accommodate the different contours of the sacral region.

In another example, the RPWT dressing (370) may comprise a roundedconfiguration with two opposing indentations, e.g., apple-shaped, asshown in FIGS. 3C and 3D. The dressing (370) may comprise a protectivelayer (372) configured on its lower surface to adhere to the skin and toseal to the sealant layer (382) on in its upper surface. The protectivelayer (372) may comprise a fold-sealing region (374) along one outeredge and a central opening (373) or an optional inner layer in place ofthe central opening. The fold-sealing region (374) may have an opencavity or recess that permits passage of tubing (375) of the sealantlayer (382) through it when the sealant layer (382) is attached. Theanterior surface of the recess and/or the tubing (375) may comprise anadhesive to further secure the tubing (375) to the recess. In otherexamples, adhesive tape may be applied to the tubing and the recessafter the sealant layer is attached to the protective layer. The sealantlayer (382) may comprise a peripheral region (391) and an inner layer(378), with a conduit system (371) in fluid communication with thetubing (375) and a wound bed. In this particular example, the conduitsystem (371) comprises a branched conduit system with open grooves orrecesses. Other variations of conduit systems are described later.

While some of the dressing systems described above comprise multipleseparate layers, other dressing may have a unibody or monolithicconfiguration. One variation of a unibody dressing (331) is shown inFIGS. 3E and 3F. As depicted in FIG. 3E, the dressing (331) may comprisea generally planar cover (330) that has an opening (332) and afold-sealing region (334). The fold-sealing region (334) may bedeformable or moldable (e.g. a moldable polymer or foam), so that itssize and shape may be modified to form an airtight seal with the skin ofthe intergluteal cleft. The opening (332) provides communication betweena wound bed and tubing (336) via a dressing port (338). The dressingport (338) and tubing (336) are shown on the other side of the sheet(330) in FIG. 3F. This configuration permits reduced pressure to beapplied to the wound bed via the tubing (336) and dressing port (338).In some variations, the port, tubing, and other devices may be embeddedin or integral with the dressing.

The dressing layers described above, e.g., the protective layer, thetransparent region, the sealant layer, occlusive cover, etc., may bemade of any elastic or flexible materials that allow the dressing toform a seal with various anatomical contours of the sacral region. Theprotective layer, the transparent region, and the sealant layers mayeach comprise any variety of materials, including but not limited topolyurethane, silicone, vinyl, polyvinyl chloride, polyisoprene, latex,rubber, thermoplastic elastomers, hydrogels, hydrocolloids, and thelike. The materials may also have a solid, lattice, open-cell foam,closed-cell foam or matrix configuration, for example.

The tubing used with the dressings described above may be configured toreduce the possibility of further pressure-induced tissue necrosis dueto load-bearing of these elements against the patient's body. Forexample, the tubing and the conduits therein may have a wider and lowerprofile relative to the skin or wound surface than similar traditionalcircular RPWT conduits, serving to reduce adverse loading to the bodysurface when the tubing is located in a weight-bearing position, e.g.,when the patient is in a sitting or prone position. For example,low-profile luminal cross-sections of the tubing may be oblong, suchthat the tubing is wider than it is deep. Examples of differentconfigurations of low-profile tubing may be viewed by taking a luminalcross-section along the line 4A-4A in FIG. 3G. FIGS. 4A-4C depicts someexamples of low-profile conduit configurations that may be used forapplying reduced pressure to wounds in the sacral region. In general,the conduits may have a flat profile to distribute loading and reducepressure points on the skin of the sacral region. For example, the depth(D10) of a conduit may be less than or equal to the width (W1) of theconduit in cross-section. The depth (D10) of a conduit may be from about2 millimeters to about 5 millimeters, for example, from about 1millimeter to about 3.5 millimeters, or from about 3 millimeters toabout 5 millimeters. As shown in FIG. 4A, tubing (440) may have multiplelongitudinal conduits (442), where the adjacent conduits are arrangedside by side. This arrangement may help to ensure that reduced pressureis maintained at the wound bed in the event one of the conduits becomesoccluded (e.g., occluded with fluid build-up, tissue matter, etc.). Inanother variation shown in FIG. 4B, tubing (450) may have a singleconduit (452) that is shaped according to the flattened profile of thetubing (450), e.g., elliptical shaped. In yet another variation depictedin FIG. 4C, tubing (460) may have a single conduit (362) that hasrounded and tapered portions.

FIG. 5A depicts a variation of a dressing (500) comprising a low-profileport (502) attached on the outer surface of the dressing, tubing (504)connected to the port (502), and a fold-sealing region (506) configuredto form an airtight seal with the skin in the intergluteal cleft. Thewidth of the port (502) is preferably a multiple of the height of theport, e.g., at least about 2 times greater than the height of the port(502), and in other examples may be as much as 3 times, 4 times, or 5times or more greater than the height. The tubing (504) extends awayfrom the dressing (500) across an edge of the dressing that isperpendicular to the edge that has the fold-sealing region (506), orlaterally when applied to the patient. In other examples, the tubing maybe oriented on the opposite edge or same edge as the fold-sealing region(506). Indeed, the tubing may have any angular orientation from about 0degrees to about 359 degrees relative to the center of the fold-sealingregion (506), and/or comprise a relative position that is generallyparallel but laterally offset to the superior/inferior orientation ofthe fold-sealing region (506).

FIG. 5B depicts another variation of a dressing (510) comprising a port(512) that is embedded within the dressing, embedded tubing (514) thatis connected to the port (512) within the dressing, and a fold-sealingregion (516). As seen in this variation, the port (512) and the tubing(514) may be directly integrated into the dressing itself, or may beembedded beneath the surface of the dressing. In certain variations of adressing for RPWT of the sacral region, the tubing may be embedded in agel-filled or otherwise soft material support. The material support maybe substantially wider than the tubing. These configurations may lowerthe profile of the dressing by reducing any protrusions above thedressing surface, which may help reduce tissue pressure when a patient'sweight is placed over the tubing. The tubing (514) extends away from thedressing (510) along an edge that does not have the fold-sealing region(516).

In some variations, the tubing may extend away from the dressing alongor within the fold-sealing region. An example of a dressing (520) wherethe tubing (524) extends from the dressing through the fold-sealingregion (526) is shown in FIG. 5C. The port (522) and the tubing (524)may be embedded within the dressing (520). Once the tubing (524) exitsthe dressing (520) via the fold-sealing region (526), it may extendthrough the intergluteal cleft (534), between the gluteal regions (530),and may curve along the gluteal crease (532). Threading the tubing (524)along these anatomical contours may help to reduce localized pressurepoints that may be introduced by the dressing, and may reduce thepatient loading on the tubing, which may help promote sufficient airflow to the wound bed for RPWT.

Another variation of a dressing that is configured to reduce pressurepoints in the sacral region due to dressing ports and tubing is shown inFIGS. 6A-6C. Dressing (600) comprises a base layer (601) with an opening(604) that provides access to a wound bed (610) for tubing (606) viaport (602). FIG. 6A depicts a top view of the dressing (600), whichshows that the tubing (606) may be partially embedded in the dressing.FIG. 6B depicts an underside, i.e., the tissue-contacting side, of thedressing (600), which shows that the port (602) may be located on thesurface of the tissue-contacting side. FIG. 6C show a cross-section ofthe dressing (600) as it is applied to the sacral region (612) of apatient. As shown there, the depth (D15) of the wound bed is greaterthan the height (H1) of the port (602), so that port (602) may notdirectly contact the wound bed (610). Positioning the port (602) withinthe enclosure of the wound bed (610) may also allow for the infusion oftherapeutic agents to the wound bed (610) via the tubing (606).

FIGS. 7A and 7B depict another variation of a dressing (700) with a port(702) that is molded from a top layer (708) of the dressing (700). Theport (702) may be molded from the top layer (708) such that it protrudesfrom the generally planer surface of the dressing (700). The port (702)may be in fluid connection to tubing (708), which may be any low-profiletubing as previously described. As shown in cross-section in FIG. 7B,the bottom layer (706) of the dressing (700) may have an opening (710)that may be positioned over a wound for RPWT. Molding the port (702)from a layer of the dressing (700) may help to ensure an airtightconnection to the dressing, and may reduce air leakage as compared toports that are separately formed and later joined to the dressing. Insome variations, a support frame or other structure may be provided inthe port or on a surface of the port to maintain its shape.

While dressings for RPWT of the sacral region may comprise one port andone opening for accessing a wound bed, other suitable dressings may havea plurality of ports and openings through with RPWT may be applied to asacral wound. Multiple ports may be provided to provide RPWT to multiplesacral wounds, or may provide a level of redundancy to ensure that thewound bed continues to receive treatment in the event one pressuresource is occluded. There may be 2, 3, 4, 5, 6, 7, 8, 9, or more etc.ports provided in the dressing to treat one or more wounds. Examples ofdressings with multiple ports are shown in FIGS. 8A and 8B. Dressing(800) may comprise a base layer (802) with a first opening (805)connected to a first port (804), and a second opening (807) connected toa second port (806). The first and second ports may be connected to asingle tube that passes through the second port and terminates at thefirst port, or by separate tubes. In other variations, the first andsecond ports may be separately connected to one or more vacuum sources.In some variations, the dimensions of the tubing may vary to helpdistribute the applied pressure across the one or more ports. Forexample, a first tubing segment (810) may be wider than a second tubingsegment (811) to help ensure that the pressure applied at the first port(804) is generally similar to the pressure applied at the second port(806). FIG. 8B depicts how the dressing (800) may be applied to thesacral region of a patient. The first port (804) and the second port(806) may be any of the ports as previously described, and both portsand the tubing (808) may be low profile to reduce pressure points in thesacral region. Additional description of low-profile tubing and ports,as well as the assembly of low-profile dressings may be found in pendingapplication Ser. No. 12/626,426, filed on Nov. 25, 2009, which has beenpreviously incorporated by reference in its entirety.

As described above, a dressing for RPWT may form an airtight seal at thesurface of the skin by using one or more adhesives. In examples where anadhesive with a high bond-strength is used to create an airtight sealwith the skin surface, it may be desirable to provide a clean dressingwithout having to replace the dressing, which may cause damage to theperi-wound skin. On the other hand, prolonged attachment of a dressingto a sacral region may lead to moisture accumulation (e.g., sweat,urine, interstitial fluid, etc.) and the possible accumulation of fecalmatter, which may damage skin not covered by the dressing. In onevariation, shown in FIG. 9, the dressing (900) has one or more layersthat may be peeled off as the top layer is dirtied. For example, oncethe top layer (902) is dirtied, it may be peeled away to reveal adressing layer (904) that is under the top layer. Since the dressinglayer (904) has been occluded from moisture and fecal exposure by thetop layer (902), removing the top layer may restore the cleanliness andsterility of the sacral dressing (900). In other variations, the surfaceof the dressing may be amenable to rinsing during normal body cleansingin the sacral area.

In some variations, instead of a dressing with a pre-configured adhesivelayer, the adhesive between the dressing and the skin of the sacralregion may be injected, as shown in FIGS. 10A-10C. This may permit, forexample, positioning and repositioning of a dressing before finallyadhering the dressing to the patient. Dressing (1000) may comprise abase layer (1002) with an adhesive channel (1004) along the perimeter ofthe dressing, where the adhesive channel (1004) is in fluidcommunication with an adhesive port (1006) and contacts the skinsurface. The adhesive channel (1004) may comprise a porous surface thatpermits controlled leakage of an injected adhesive out of the channel(1004) and adhere to the skin. The dressing (1000) may have any size andshape as described above, and may have a narrow sealing region (1008) toaccommodate anatomical contours of the sacral region, e.g., the tailbone. The adhesive channel (1004) may substantially follow the perimeterof the base layer (1002), or may enclose an area that is smaller thanthe area of the base layer (1002). For example, the adhesive channel(1004) may be adjusted to outline the perimeter of the sacral wound. Theadhesive port (1006) may also comprise a valve mechanism, e.g., aone-way valve, and may be configured to interface with standard syringeand/or tubing connectors. Another variation of a dressing (1020) with arectangular geometry is shown in FIGS. 10B and 10C. The dressing (1020)comprises a base layer (1022) with an adhesive channel (1024) that isconnected to an adhesive port (1026). FIG. 11 depicts a dressing (1100)comprising an adhesive conduit (1102) and adhesive port (1104) that hasa rounded, elliptical shape. Examples of injectable adhesives includecyanoacrylates, silicone, silicone gels, hydrocolloid, hydrogel,urethanes and other liquid adhesives.

One variation of a dressing (1200) is shown in FIGS. 12A-12C. Thedressing (1200) comprises a sealant layer (1202) with a roundedgeometry, that may be characterized as two intersecting ellipticallobes, with indentations at their intersection, as depicted from a topperspective view in FIG. 12A. The dressing (1200) may also have afold-sealing region (1204), where the size and shape of the fold-sealingregion (1204) may be adjusted by injecting a fluid through an inflationport (1208). A tubing (1206) may be partially embedded into the dressing(1200) to provide a channel between a reduced pressure source and awound bed. The tubing (1206) of the dressing (1200) in FIGS. 12A-12Cextends away from the dressing via the inflatable fold-sealing region(1204), and may be partially or wholly embedded in the fold-sealingregion. For example, the fold-sealing region may be filled with a gel orother similarly compliant material, with the tubing embedded therein toprovide a low-profile dressing. FIG. 12B illustrates the underside ofthe dressing (1200), e.g., the tissue-contacting side. In thisvariation, the dressing (1200) also comprises an arrangement of conduits(1210) that may be connected to a reduced pressure source via the tubing(1206) to provide reduced pressure to a wound site. The conduits (1210)depicted in FIG. 12B comprise an open configuration, i.e., the conduits(1210) have an open geometry along their longitudinal length such thatthe interior surface of the conduits are exposed. In other examples,depicted in FIG. 12C, the conduits (1210) may comprise a removable ortrimmable occlusion structure (1213) there within, that may be used toselectively open or expose portions of the conduit (1210), and may beused to customize the conduit pathways in communication with the tubing(1206). The occlusion structure (1213) may comprise, for example, afitted elongate silicone or polymeric member that may be removablyinserted or provided within the conduit (1210) or a selectivelyremovable adhesive layer. The occlusion structure may comprise a unibodydesign, or may be segmented at preselected locations to facilitatecertain conduit configurations (e.g. at branch points of the conduit).In other examples, occlusive tape may be applied to seal off portions ofthe conduit where a vacuum pathway is not desired. These configurationsmay allow for the treatment of off-center wounds relative to body planesand treatment of multiple wounds with the same dressing.

In another variation, a dressing (1300) shown in FIGS. 13A-13C comprisesa fold-sealing region (1304) that comprises an open or exposed recess orcavity (1305), as depicted along the inferior and anterior surfaces ofFIGS. 13A-13C. In some variations, this may allow the user to press anadhesive surface (1306) of the fold-sealing region (1304) onto the skinof an intergluteal cleft. The adhesive surface (1306) may be pressedonto the skin to form an airtight seal by running a finger along thesurface of the fold-sealing region (1304) to contact the interglutealskin. In other variations, the dressing may be provided with a suturewithin the volume (1305), which may be tensioned and pressed such thatthe length of the tensioned suture is drawn along the surface of thedressing contacting the skin of the intergluteal cleft. This may help tosmooth the adhesive surface (1306) against the skin. FIGS. 13B and 13Calso depict how adhesive regions (1312) may be occluded by a supportelement (1313), which may be removed prior to applying the dressing tothe sacral region.

Another variation of a dressing for RPWT of the sacral region isillustrated in FIG. 14. As shown there, the dressing (1400) may comprisea base layer (1402) that is shaped as two intersecting ellipses, as wellas a fold-sealing region (1404) that may have a first elastic region(1406) and a second elastic region (1408), as previously described. Theelasticity of the first elastic region (1406) may be different from thesecond elastic region (1408), and the elastic properties of these tworegions (1406) and (1408) may be different than the base layer (1402).In other variations, the fold-sealing region may comprise a singletriangular or tapered elastic region. Fold-sealing regions with portionsof different elastic characteristics may help the dressing to form asubstantially airtight bond with the skin in the intergluteal cleft.

The dressings described above may also be configured with supportmechanisms that redistribute contact forces acting on the wound bedand/or peri-wound skin, and may also serve to help maintain the airtightseals of the dressings. For example, a substantially airtight sealaround a wound may be maintained by increasing the mechanical forcespushing or acting on the adhesive when the patient sits or lies on thedressing, thereby increasing the seal of the adhesive to the skin. Insome variations of dressings for RPWT of the sacral region, a secondarydevice may be adhered to the skin the sacral region over the wounddressing to help divert any body weight off the dressing, and to theperiphery of the wound dressing. Examples of devices that may helpredistribute body weight from the dressing to the periphery of thedressing are shown in FIGS. 15A-15C, 16A and 16B, and 17A-17D. Thesedevices may have a raised structure whose border sits outside the woundarea, e.g., over the unwounded region. This raised structure may be, forexample, inflatable, foam-filled, and/or gel-filled. Such compliantraised structures or protrusions may act to shield the wound bed fromadditional pressure while helping the dressing to maintain skin contactaround the wound when the patient is in a sitting or prone position. Theraised structure may have any suitable geometry that substantiallysurrounds the wound bed.

FIGS. 15A and 15B depict a supportive device (1500) that may comprise araised structure (1502) with a rectangular geometry. As shown there, theraised structure (1502) has an opening (1504) that may be configured toallow tubing to pass therethrough. FIG. 15B illustrates one example howsupportive device (1500) may be applied on top of a dressing for RPWT ofthe sacral region, where the tubing extending from the dressing passesthrough the opening (1504). Alternatively, the raised structure may havea closed-shape, such as in the supportive device (1510) shown in FIGS.15C and 15D. The raised structure (1512) has a closed geometry, but maycomprise an elevated region (1514) that may be suitable for the dressingtubing to pass therethrough. The elevated region (1514) may also beshaped to help guide the tubing in a certain direction. For example,FIG. 15D shows that the tubing (1516) is guided through the elevatedregion (1514), along the intergluteal cleft (1520), and curving alongthe gluteal crease (1522). This may help to reduce any pressure pointsin the sacral region that may arise from the tubing (1516).

Supportive devices may also have round geometries, as shown in FIGS. 16Aand 16B. Supportive device (1600) may have an elliptical shape with anindentation along the perimeter of the ellipse. The supportive device(1600) may have a raised structure (1602) that may be shaped to matchthe overall shape of the supportive device. The raised structure (1602)may be expanded by injecting fluids through a port (1604), where thefluids may be substantially conformable, compliant, and may haveshape-memory properties. The supportive device (1600) may haveattachment features such as adhesives, notches, snaps, and the like tointerface with a dressing (1610). FIG. 16B illustrates one variation ofa dressing that may be configured to attach with the supportivestructure (1600). A supportive structure may also have an oval orcircular geometry, as depicted in FIGS. 17A-17D. Supportive device(1700) may comprise a circular inflatable raised structure (1702), andone or more adhesive tabs (1706). The adhesive tabs (1706) may be shapedaccording to the contours of the sacral region, and may be arrangedopposite each other, or distributed around the raised structure (1702)to securely attach the supportive structure (1700) in the sacral region.The raised structure (1702) may be inflated via a port (1704). FIG. 17Bdepicts the supportive structure (1700) attached to the sacral regionover a dressing for RPWT. As seen there, the tubing (1712) of thedressing extends from the dressing along the intergluteal cleft andcurves along the gluteal crease. FIGS. 17C and 17D depict cross-sectionsof the supportive structure (1700) and the dressing (1710) before andafter the supportive structure is applied onto the dressing. FIG. 17Cshows the dressing (1710) enclosing a wound bed (1714) with the tubing(1712) extending from the dressing. FIG. 17D shows the supportivestructure (1700) applied over the dressing (1710) such that the raisedstructure (1702) presses the edges of the dressing (1710) against theskin surface. This may help the dressing (1710) maintain a sufficientlyairtight bond with the skin in the sacral region for RPWT of the woundbed (1714). The supportive device (1700) may be applied to the dressing(1710) where the raised structure (1710) is initially deflated. Theadhesive tabs (1706) may be used to attach the deflated supportivedevice (1700) to the skin of the sacral region. Then, the raisedstructure (1702) may be inflated, e.g., with a syringe, so that theraised structure presses the edge of the dressing against the skin. Thesupportive device may include pressure sensors, volume indicators andthe like to help the user to consistently apply the same degree ofinflation.

Other devices may also be applied to a dressing for RPWT of the sacralregion to help the dressing maintain a substantially airtight seal withthe skin surface. FIGS. 18A-18D depict various elastic support garmentsthat may be configured to help keep the edges of the dressing fromlifting off the skin surface, and may apply sufficient force to thedressing to help maintain its adhesion during normal patient activity.These supportive garments may provide separate support to the sacraldressing for RPWT. FIG. 18A depicts a supportive undergarment (1800)that may be placed over the dressing (1802). The supportive undergarment(1800) may provide a distributed pressure across regions of the dressing(1802) to help it maintain secure contact with the skin. FIG. 18Bdepicts one variation of a supportive boxer (1810) that may comprise asuper-elastic region (1812) in the proximity of the sacral region wherethe dressing may be applied to press the dressing against the skin.Optionally, the boxer (1810) may comprise an elastic waistband (1816)and elastic leg bands (1814) that may create a sufficiently airtightseal for reduced pressure to be applied to the entire region enclosed bythe boxer (1810). The waistband and leg bands may also comprise anadhesive to provide sealing. FIGS. 18C and 18D depict a supportivestrap-based undergarment (1820) that may provide more localized pressurealong the perimeter or outer edges of the dressing using straps (1822).The arrangement of straps (1822) may be varied and adjusted according tothe geometry and size of the dressing.

The application of a dressing for RPWT of the sacral region such that asubstantially airtight seal is created may be challenging due to thevariable contour of the gluteal regions and the intergluteal cleft. Insome variations, flattening out the gluteal regions about theintergluteal cleft may facilitate a better seal between the dressing andthe skin. For example, stretching out the skin in the sacral region asdepicted in FIGS. 19A and 19B may help with applying the dressing to thesacral region. The device (1900) may have a dressing (1906), and atleast two tabs (1905) extending from the dressing (1906). The tabs(1905) may extend from each other in opposite directions, and may eachcomprise a central adhesive region (1907), elastic region (1902),intermediate adhesive region (1903), lateral adhesive region (1904). Thetabs facilitate the application lateral forces by the dressing (1906) toflatten the contour between the two gluteal regions (1920), i.e., byincreasing the width of the intergluteal cleft (1922), as shown in FIG.19B. The width of the intergluteal cleft (1922) may be increased becausethe elastic region (1902) and the adhesive region (1904) act to pull thegluteal regions (1920) in the direction of the arrows (1910). Forexample, the first adhesive region (1903) may be adhered to each of thegluteal region (1920). Then, the tabs (1905) may be pulled in thedirection of arrows (1910), which may increase the width or otherwisespread the intergluteal cleft (1922) and stretch the skin surface of thesacral region. To retain this stretched configuration, the secondadhesive regions (1904) may be adhered more laterally, e.g., adhered tothe skin toward the lateral portions of the buttocks or hips. Thecentral adhesive region (1907) of the dressing (1906) may then beapplied to the stretched sacral region. After the dressing (1906) hasbeen applied, the stretched skin surface may be released by releasingthe second adhesive region (1904), and optionally, the first adhesiveregion (1903). The tabs may also be cut or otherwise separated from thedressing (1906) if desired. The first and/or second adhesive regions mayalso remain adhered laterally to the patient's skin if it is desirableto retain the stretched skin surface. In general, increasing the widthof the intergluteal cleft (1922) may allow better access to the skinwithin and along the cleft, so that the dressing may be pressed againstthe skin to form a substantially airtight seal. In some variations, thewidth of the intergluteal cleft may be increased by using retractorinstruments with traction or adhesive surfaces that may be insertedwithin the intergluteal cleft inferior to the desired dressing site, andused to widen or flatten the cleft as the dressing is applied. Theinstrument is then withdrawn after the dressing has been securely sealedto the skin surface.

Another device that may be used with a dressing for RPWT of the sacralregion is shown in FIGS. 20A and 20B. Device (2000) may comprise adressing (2012), dressing tubing (2014), a foam or sponge region (2002),and a vacuum tube (2006) connected to the sponge region (2002), and anabsorbent material (2004) around the sponge region (2002). The device(2000) may be worn by a patient similar to a diaper, where the spongeregion (2002) may be used to capture fecal matter that may be drawn awayfrom the patient via the tube (2006). The absorbent material (2004) maybe positioned as shown to absorb and wick away urine and excrement.These features may help to keep the dressing (2012) and dressingadhesive (2010) clean and dry, which may help to maintain and prolong anairtight seal between the dressing (2012) and the skin of the sacralregion. As previously described, a dressing tubing (2014) may beprovided separately from the vacuum tube (2006) to provide reducedpressure to the area under the dressing (2012). FIG. 20B depicts anothervariation of a device (2030) where the adhesive portion (2031) of thedressing is larger and surrounds the sponge region (2032). The spongeregion (2032) may have a three-dimensional shape, and one or moretapers, such as a triangular prism. This sponge region (2032) may beconnected to a vacuum tube (2034) to help remove fecal matter, which mayhelp to maintain a substantially airtight seal between the skin and thedressing, while a dressing tubing (2036) may provide reduced pressure tothe area under the dressing. FIG. 20C is a cross-section of the device(2030) shown in FIG. 20B.

Dressings may have different geometries and shapes to accommodate avariety of anatomical contours. FIG. 22 depicts a dressing that isoval-shaped or ellipse-shaped with a tapered end. The outer edge (320)of the dressing may have adhesive properties to enclose the centralregion of the dressing for RPWT. The fold-sealing region (321) may belocated at the tapered end. Dressings may have a shape that has one,two, three or more lobular regions. For example, FIG. 23 depicts aquad-lobular dressing, with a first lobular region (324 a), a secondlobular region (324 b), a third lobular region (325 a), and a fourthlobular region (325 b). Dressings may also have lobular regions that arenot symmetric across any axis, or lobular regions that are symmetricacross one axis but not other axes, e.g., bilaterally symmetric. Theouter edge (322) of the dressing may have adhesive properties aspreviously described. The fold-sealing region (323) may be located alonga central axis of the dressing. FIG. 24 depicts a tri-lobular dressing,with a first lobular region (328), a second lobular region (329 a), anda third lobular region (329 b). The first lobular region (328) may havea notch along the outer edge (326) of the dressing, and the fold-sealingregion (327) may be located adjacent to the notch.

Another example of a dressing (390) that may be used for RPWT in thesacral region is shown in FIG. 25. As shown there, the dressing (390)may be shaped so that it flares outwardly to help create an airtightseal with the gluteal regions, e.g., the dressing may have a shapesimilar to a trapezoid where the base is divided by an elongate notchthat may align along the length of the intergluteal cleft. The dressing(390) may have a base layer (394) with a transparent region (392)therein so that a sacral wound may be observed in the course of RPWT.The dressing (390) may also comprise an opening (398) that providesfluid access to the wound bed via tubing (395), which may be attached toa dressing port (396).

Methods of applying dressings and devices for RPWT of the sacral regionare also described herein. Any of the dressings described above may beconfigured to work in a system in which a first dressing layer, e.g., abase layer, is placed over the wound first to provide a protective layerto the surrounding healthy skin while a second dressing layer may beplaced subsequently. The base layer may comprise a fold-sealing regionfor creating an airtight seal between the dressing and the skin of theintergluteal cleft. The base layer may also comprise a trimmablewound-contacting region such that the sealing surfaces of the base layercover the region around the wound, and the trimmable wound-contactingregion may be positioned over the wound. This arrangement may promotefocal application of RPWT to the wound bed, with reduced impact on theperi-wound tissue. Applying RPWT primarily to the wound bed and not theperi-wound regions may help to protect the surrounding healthy skin fromdegrading, e.g., by maceration. Once the base layer has been applied tothe sacral region, a second dressing layer, e.g., a sealant layer, maybe attached on top of the base layer to deliver reduced pressure to thewound bed. The attachment junction of the sealant layer to the baselayer may be substantially airtight.

One example of a method of applying a dressing to a sacral region forRPWT is shown in FIG. 21. In this variation, a first dressing layer,e.g., base layer (2100), comprising a wound-contacting region (2105) anda fold-sealing region (2102) may be prepared to accommodate the sacralwound (2110). Preparing the base layer (2100) may comprise trimming thewound-contacting region (2105) so that the trimmed aperture approximatesthe perimeter of the wound (2110), and allows a sufficient wound bedsurface to be exposed to reduced pressure. In some variations of awound-contacting layer, one or more pre-made apertures or perforationsmay be provided to help facilitate trimming the base layer to a shapethat approximates the shape of the wound. For example, a pre-made hole(2105) may be located in a central portion of the wound-contactingregion (2104), and may be expanded by cutting away portions of thewound-contacting region to conform to the geometry of the wound. Thebase layer (2100) may then be placed on the patient and secured to forma substantially airtight seal with the skin surface. The base layer(2100) may be applied such that the fold-sealing region (2102) is firstapplied to create a sufficiently airtight bond with the skin of theintergluteal cleft. Spreaders and devices as previously described may beused to facilitate sealing with the intergluteal cleft. For example, insome variations of a dressing, a suture may be used to thread thetapered portion of the fold-sealing region (2102) into the interglutealcleft. Then, the substantially planar portion of the base layer (2100),which may include the wound-contacting region, may be applied over thegluteal regions (2120). Optionally, an additional dressing layer may beapplied on top of the base layer (2100), where the additional dressinglayer may be foam or gauze. Once it has been confirmed that asufficiently airtight bond has been created between the base layer(2100) and the skin, a second dressing layer, e.g., a sealant layer(2106), may be applied over the dressing base layer. Once the sealantlayer (2106) has been attached to the dressing base layer (2100) and isconfirmed to be substantially airtight, RPWT of the wound (2110) maycommence.

Methods of removing the dressing (e.g., for cleaning, sterilizing,positional adjustments, etc., or at the completion of the therapy) mayvary according to the mechanism(s) by which the dressing is applied tothe skin. In some variations, the first dressing layer, may remainattached to the skin, while additional dressing layer above the firstlayer may be removed. This may reduce the likelihood of damagingperi-wound skin, which may be easily macerated as the dressing is pulledaway. Some dressing layers may be attached to each other and/or to theskin surface using differential strength adhesives or other mechanicalfixation techniques may allow for easy removal of any of the dressinglayers, e.g., the sealant layer (2106) from the base layer (2100). Insome variations, the seal between the dressing layers and/or between thedressing and the skin is a temperature-sensitive adhesive. Removal of adressing layer that is attached using a temperature-sensitive adhesivematerial may comprise heating the dressing to weaken the bond betweenthe dressing layers, and subsequently removing the top dressing layeronce has been loosened. While bonding between the base layer and thesealant layer as described above may be facilitated bypressure-sensitive adhesives, other bonding mechanisms may be used,including bonding by electrostatic forces, self-sealing materials,magnetic interactions, vacuum-gasket seals, or any other mode thatenables an airtight juncture to be formed between the two elements. Ingeneral, techniques that allow for the removal of a dressing layerwithout damaging the skin surface as the layer is pulled away may beused.

It is to be understood that this invention is not limited to particularexemplary embodiments described, as such may, of course, vary. It isalso to be understood that the terminology used herein is for thepurpose of describing particular embodiments only, and is not intendedto be limiting, since the scope of the present invention will be limitedonly by the appended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included in the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, some potential andpreferred methods and materials are now described. All publicationsmentioned herein are incorporated herein by reference to disclose anddescribe the methods and/or materials in connection with which thepublications are cited. It is understood that the present disclosuresupersedes any disclosure of an incorporated publication to the extentthere is a contradiction.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “ablade” includes a plurality of such blades and reference to “the energysource” includes reference to one or more sources of energy andequivalents thereof known to those skilled in the art, and so forth.

The publications discussed herein are provided solely for theirdisclosure. Nothing herein is to be construed as an admission that thepresent invention is not entitled to antedate such publication by virtueof prior invention. Further, the dates of publication provided, if any,may be different from the actual publication dates which may need to beindependently confirmed.

The preceding merely illustrates the principles of the invention. Itwill be appreciated that those skilled in the art will be able to devisevarious arrangements which, although not explicitly described or shownherein, embody the principles of the invention and are included withinits spirit and scope. Furthermore, all examples and conditional languagerecited herein are principally intended to aid the reader inunderstanding the principles of the invention and the conceptscontributed by the inventors to furthering the art, and are to beconstrued as being without limitation to such specifically recitedexamples and conditions. Moreover, all statements herein recitingprinciples, aspects, and embodiments of the invention as well asspecific examples thereof, are intended to encompass both structural andfunctional equivalents thereof. Additionally, it is intended that suchequivalents include both currently known equivalents and equivalentsdeveloped in the future, i.e., any elements developed that perform thesame function, regardless of structure. The scope of the presentinvention, therefore, is not intended to be limited to the exemplaryembodiments shown and described herein. Rather, the scope and spirit ofpresent invention is embodied by the appended claims. For all theembodiments described herein, the steps of the method need not beperformed sequentially.

1. A device to treat a region of a patient having a skin fold,comprising: a base layer comprising a first surface, a second surface,an interior region and an outer perimeter, and a non-planar sealingregion located about the outer perimeter of the base layer; tubingdirectly attached to the second surface of the base layer; and anadhesive located on the base layer and on at least a portion of thesealing region.
 2. The device of claim 1, wherein the non-planar sealingregion comprises a tapered region and a taper peak, wherein the taperedregion has a taper length and a taper slope.
 3. The device of claim 2,wherein the non-planar sealing region comprises a plurality of taperedregions and taper peaks.
 4. The device of claim 2, wherein the taperedregion comprises one or more elastic regions configured to change thetaper slope when stretched.
 5. The device of claim 2, wherein thenon-planar sealing region further comprises a cavity.
 6. The device ofclaim 5, wherein the non-planar sealing region further comprises apushing element located in the cavity, wherein the pushing element isconfigured to push outwardly against the cavity.
 7. The device of claim6, wherein the pushing element comprises a filament that is coupled tothe taper peak and extends along the taper length.
 8. The device ofclaim 6, wherein the pushing element comprises a sack containing anexpandable element.
 9. The device of claim 8, wherein the expandableelement is a foam.
 10. The device of claim 8, wherein the expandableelement is a fluid.
 11. The device of claim 1, wherein the non-planarsealing region is integrally formed with the base layer.
 12. The deviceof claim 1, wherein the non-planar sealing region is attached to thebase layer at the point of manufacture.
 13. The device of claim 1,further comprising tubing located within the base layer.
 14. The deviceof claim 1, further comprising tubing directly attached to the firstsurface of the base layer.
 15. The device of claim 1, wherein the tubingis directly attached to both the first surface and the second surface ofthe base layer.
 16. A device to treat a region of a patient having askin fold, comprising: a base layer comprising a first surface, a secondsurface, an interior region and an outer perimeter, and a non-planarsealing region located about the outer perimeter of the base layer; andan adhesive located on the base layer and on at least a portion of thesealing region; wherein the non-planar sealing region comprises: atapered region, wherein the tapered region has a taper length and ataper slope; a taper peak; a cavity; and a pushing element located inthe cavity and comprising a sack containing an expandable element,wherein the pushing element is configured to push outwardly against thecavity and wherein the expandable element is a fluid.
 17. The device ofclaim 16, wherein the non-planar sealing region comprises a plurality oftapered regions and taper peaks.
 18. The device of claim 16, wherein thetapered region comprises one or more elastic regions configured tochange the taper slope when stretched.
 19. The device of claim 16,wherein the pushing element comprises a filament that is coupled to thetaper peak and extends along the taper length.
 20. The device of claim16, wherein the non-planar sealing region is integrally formed with thebase layer.
 21. The device of claim 16, wherein the non-planar sealingregion is attached to the base layer at the point of manufacture. 22.The device of claim 16, further comprising tubing located within thebase layer.
 23. The device of claim 16, further comprising tubingdirectly attached to the first surface of the base layer.
 24. The deviceof claim 16, further comprising tubing directly attached to the secondsurface of the base layer.
 25. The device of claim 16, furthercomprising tubing directly attached to both the first surface and thesecond surface of the base layer.